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How Do Dangerous Prescription Drugs Make it Onto the Market?

March 23, 2012Colson Hicks Eidson

The pharmaceutical industry is a multi-billion dollar industry in the United States. Approximately two-thirds of visits to the doctor result in prescription drug treatment, says the Food and Drug Administration (FDA). With so many Americans taking prescription drugs, there is a drug available for virtually every type of illness and medical condition.

While drugs do undergo strict and lengthy testing before release to the public, it can be hard to know a drug’s true side effects until a larger sample of users takes the drug. Other times, drug companies streamline their testing in order to obtain FDA approval quicker. In the case of Yaz, Bayer failed to disclose data linking the drug to a high risk of heart attack, stroke and blood clots in women. Once released to the public, reports of adverse side effects eventually lead to a warning or recall by the FDA.

An FDA recall comes in three different levels of classification:

A Class 1 recall means there is a reasonable probability that using the drug will cause serious adverse health consequences or death

A Class 2 recall means that using the drug may cause temporary or medical reversible adverse health consequences, or the probability of serious adverse health consequences is remote

A Class 3 recall means that using the drug is not likely to cause adverse health consequences

Short of a recall, a product warning by the FDA requires drug makers to disclose drug risks in advertising and product packaging.